Manager, Quality Assurance

Intercept Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 33 days ago

Job Description

POSITION SUMMARY:

This position is responsible for supporting Chemistry Manufacturing and Controls (CMC) quality assurance operations and reports to the Director of Quality Assurance. It is a full-time position requiring in-depth experience in quality assurance operations as it relates to internal operations and collaborative processes with external vendors. This position is Quality Systems and pharmaceutical vendor/supplier focused; it entails management of both internal and external quality system processes related to vendor/supplier activities, and requires knowledge of applicable regulations (both US and international). This position has no reports, and may require domestic and international travel.

ESSENTIAL FUNCTIONS:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

The individual in this position will be accountable for the following:

  • Maintenance of Vendor/Supplier Quality Documents as part of Intercept's Vendor Management program;
  • Represent Quality in internal and external meetings and teleconferences;
  • Maintain/use the electronic document management (EDMS) system and quality management system (QMS);
  • Assist/generate/maintain Quality System metrics and reports for Intercept's executive team as well as part of the Vendor Management program;
  • Gather data and generate Quality reports for internal/external use or regulatory submission (e.g., Annual Product Review, Annual Reports);
  • Work with the Procurement Team, Supply Chain, internal stakeholders, and/or Vendors directly to facilitate Vendor/Supplier Qualification per Intercept Policy & Procedures;
  • Assist & facilitate the scheduling of Vendor/Supplier audits and accordingly maintain the Vendor/Supplier module in the QMS;
  • Assist in the management and processing of quality documents to ensure their compliance with internal SOPs and FDA regulations;
  • Perform and/or assist in the performance of Quality Assurance Batch Record Review up to and including generation of a Certificate of Analysis, Certificate of Release, and maintaining a log of Product Disposition for generation of metrics and other reports as necessary;
  • Ensure complete Batch Record History file is maintained per Intercept Policies and Procedures;
  • Implementation/improvement of existing quality processes to ensure continuously appropriate/compliant operation of quality processes internally and with external vendors;
  • Prepare/participate in on-site regulatory audits/inspections, and support vendor audits/inspections, as needed;
  • Service as a resource for other departments within Intercept for facilitating the completion of and filing of Quality System documentation;
  • Other duties as assigned.

Experience and Skills

QUALIFICATIONS:

Minimum requirements:

  • BS/BA in Organic Chemistry, Biochemistry, or a relevant science
  • At least 5 years of pharmaceutical drug QA experience
  • Fluent in English, both spoken and written

REQUIRED KNOWLEDGE AND ABILITIES:

  • Working knowledge of the following:
  • Internal quality system operations and collaborative oversight in a GXP regulated environment for pharmaceuticals, relating to product development and commercial manufacturing.
  • QA oversight and collaboration with product development/vendors to facilitate the review, approval, and finalization of Vendor provided Quality Documentation related to the manufacture and testing of pharmaceutical Drug Substance and Drug Product under GMP.
  • Quality principles and pharmaceutical industry trends.
  • Applicable CFR, ICH, and GXP regulations
  • Skills in the following areas:
  • Strong verbal and written communication skills are essential
  • Excellent organization and multi-tasking skills
  • Exceptional interpersonal skills, positive attitude, and problem-solving capabilities
  • Ability to work independently and prioritize with minimal daily instruction
  • Ability to think strategically in order to improve current internal and vendor processes
  • Proficient in the following areas and computer applications:
  • Electronic Document Management Systems
  • MS word
  • PowerPoint
  • Microsoft office
  • Excel with emphasis in trend charting and data analysis.

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